Development of Sotair for Improving Performance and Minimizing Complications of Manual Ventilation

开发 Sotair 以提高手动通气的性能并最​​大程度地减少并发症

• 批准号: 10708832
• 负责人: Prathamesh Prabhudesai
• 金额: $ 94.54万
• 依托单位: SAFEBVM CORP.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708832
• 关键词: Acute; Acute Lung Injury; Acute Respiratory Distress Syndrome; Adult; Air; Air Movements; Air Pressure; American Heart Association; Anesthesia procedures; Animals; Artificial Respiration; Aspiration Pneumonia; Award; Blood Pressure; Breathing; COVID-19 pandemic; Cadaver; Calibration; Cardiopulmonary; Caring; Chest; Clinical; Clinical Trials; Computer software; Critical Illness; Dangerousness; Data; Development; Devices; Disease; Dysbarism; Emergency Situation; Engineering; Ensure; Family suidae; Feedback; Future; Gases; Grant; Guidelines; Hemorrhagic Shock; Hospitals; Human; Injury; Institutional Review Boards; Insufflation; Intubation; Legal patent; Life; Lung; Lung Compliance; Manuals; Masks; Measurement; Mechanical Ventilators; Mechanical ventilation; Modeling; Monitor; Operating Rooms; Oxygen; Patient Care; Patients; Patients' Rooms; Pattern; Performance; Periodicity; Phase; Pneumothorax; Production; Provider; Pulmonary Inflammation; Qualifying; Quality Control; Quality of Care; Randomized, Controlled Trials; Resistance; Respiratory distress; Safety; Series; Small Business Innovation Research Grant; Stomach; System; Techniques; Technology; Testing; Tidal Volume; Time; Tissues; Treatment Cost; Tube; United States National Institutes of Health; Vent; Ventilator; Volutrauma; Vomiting; Work; aspirate; clinically relevant; commercialization; cost; design; efficacy evaluation; efficacy study; experience; haptics; improved; improved outcome; innovation; manufacture; mortality; next generation; porcine model; pressure; prevent; primary outcome; prototype; response; secondary outcome; sensor; software development; trial design; ventilation

Abstract Bag valve mask (BVM) resuscitators are the gold standard of emergency airway management and artificial respiration for patients who are not breathing adequately. However, a well-documented problem with BVMs is that they are often misused, regardless of the qualifications and experience of the provider, which can lead to dangerous complications such as gastric insufflation. Gastric insufflation can lead to decreased oxygen delivery to tissue, causing vomiting and aspiration. Patients can subsequently develop aspiration pneumonia, which has a mortality rate as high as 70%. Subsequently, patients who have developed aspiration pneumonia can even develop acute lung injury (ALI) and acute respiratory distress syndrome (ARDS). Thus, a solution to the problem of unsafe manual ventilation with BVMs—and the costly and dangerous complications they can cause—is urgently needed. In response to these concerns, SafeBVM is developing the Sotair™ series of products, a set of devices that attach to standard BVM resuscitators and prevent the dangerously high pressure, flow rates, and volumes of airflow that frequently occur during manual ventilation. The proposed device will control flow rates by integrating flow blocking and pressure release valves. It will provide haptic and audiovisual feedback to providers to adjust their ventilation techniques to ensure safe, personalized breaths are delivered during emergencies. During our NSF Phase I project, SafeBVM established the design parameters that control airflow and pressure and developed software for monitoring and testing the device. A prototype version of the Sotair Adult device was also manufactured and demonstrated that it successfully and consistently controls airflow patterns in a cadaver model. This NIH Direct to Phase II will involve engineering to improve the device, animal studies of efficacy in a model of hemorrhagic shock, and a pivotal clinical trial to demonstrate non-inferiority compared to a mechanical ventilator. This will be accomplished through the following three aims: 1) Engineering/design work to optimize a next-generation Sotair device and evaluate performance against commonly used devices like the LUCAS chest compression device and O_two smart bag, 2) Determine the efficacy of Sotair device in reducing gastric insufflation, aspiration, barotrauma, and improving outcomes in a hemorrhagic shock porcine model, and 3) Conduct a clinical trial in non-emergency operating room (OR) patients to demonstrate non-inferiority of Sotair device compared to mechanical ventilation and prevent gastric insufflation. SafeBVM’s proposed innovation will prevent the numerous complications from the high pressure, flow rates, and volumes of airflow that frequently occur when using BVMs. This technology will successfully develop the Sotair™ series of products as a standard of practice for first-line care in airway management.

抽象的 袋阀面罩 (BVM) 复苏器是紧急气道管理和人工呼吸的黄金标准 呼吸不充分的患者的呼吸。然而，BVM 的一个有据可查的问题是 无论提供者的资格和经验如何，它们经常被滥用，这可能导致 危险的并发症，例如胃胀气。胃充气会导致氧气输送减少 进入组织，引起呕吐和误吸。患者随后可能会发展为吸入性肺炎， 死亡率高达70%。随后，出现吸入性肺炎的患者甚至可以 发生急性肺损伤（ALI）和急性呼吸窘迫综合征（ARDS）。于是，问题的解决方案 使用 BVM 进行不安全的手动通气及其可能导致的昂贵且危险的并发症的原因 急需。针对这些问题，SafeBVM 正在开发 Sotair™ 系列产品， 一组连接到标准 BVM 复苏器并防止危险高压的设备， 手动通气期间经常出现的流速和气流量。提议的设备 将通过集成阻流阀和压力释放阀来控制流量。它将提供触觉和 向提供者提供视听反馈，以调整他们的通气技术，以确保安全、个性化的呼吸 紧急情况下交付。在我们的 NSF 第一阶段项目中，SafeBVM 确定了设计参数 控制气流和压力，并开发了用于监控和测试设备的软件。原型 Sotair Adult 版本的设备也已制造出来，并证明它成功且一致 控制尸体模型中的气流模式。 NIH 直接进入第二阶段将涉及工程来改善 装置、失血性休克模型功效的动物研究以及证明 与机械呼吸机相比具有非劣效性。这将通过以下三个目标来实现： 1) 优化下一代 Sotair 设备并评估性能的工程/设计工作 常用的设备如LUCAS胸外按压设备和O_two智能包，2）确定 Sotair 装置在减少胃充气、误吸、气压伤和改善预后方面的功效 失血性休克猪模型，以及 3) 在非急诊手术室 (OR) 患者中进行临床试验 证明 Sotair 装置与机械通气相比的非劣性并预防胃病 充气。 SafeBVM 提出的创新将防止高压带来的众多并发症， 使用 BVM 时经常出现的流速和气流量。这项技术将成功 开发 Sotair™ 系列产品作为气道管理一线护理的实践标准。